Zostrix High Potency Foot Pain Relief

Product NDC: 61787-556
11-digit product format: 617870556
Labeler code: 61787
Product ID: 61787-556_29c8c84e-3b9a-40aa-88ca-d024bf2d2c1a
Type: HUMAN OTC DRUG
Nonproprietary name: capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: MEDTECH PRODUCTS INC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-10-22
Marketing end: 0000-00-00
Substance: CAPSAICIN
Active strength: 1 mg/g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61787-556		D	Discontinued by firm		2026-10-05
excluded package	package	61787-556	61787-556-02	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61787-556-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61787-556-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61787-556-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61787-556-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61787-556-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61787-556-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61787-556-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61787-556-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61787-556-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61787-556-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61787-556-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61787-556-02	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61787-556-02	2020-12-14	C162847	48780-1	9855e2a2-4b60-60a7-e053-dbdaa90a05bd	Zostrix HP Foot Pain Relief 61787-556
61787-556-02	2019-11-27	C162847	48780-1	9855e2a2-4b60-60a7-e053-dbdaa90a05bd	Zostrix HP Foot Pain Relief 61787-556

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-556-02	GM - Gram	61787-556	999c39a9-2430-4cfa-9022-35d75241600f	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZOSTRIX HIGH POTENCY FOOT PAIN RELIEF (CAPSAICIN) CREAM [HEALTH CARE PRODUCTS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61787-556-02	61787055602	1 TUBE in 1 CARTON (61787-556-02) > 56.6 g in 1 TUBE	1 tube	2013-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zostrix HP Foot Pain Relief 61787-556	MEDTECH PRODUCTS INC \| Denison Pharmaceuticals, LLC	2022-03-03	HUMAN OTC DRUG LABEL	3